| Code | 1741E | ||||||||||
| MA number | EU/1/22/1653/001 | ||||||||||
| Product Form: | sol inf 1x0,5 ml (liek.inj.skl.) | ||||||||||
| MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | PTC Therapeutics International Limited, Ireland | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
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| Shelf life: | 45 | ||||||||||
| Container: | glass vial |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 18.07.2022 |
| Validity: | 18.07.2027 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 03.11.2023 |
